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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04170127
Other study ID # WroclawMU6354J
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2019
Est. completion date August 2, 2019

Study information

Verified date November 2019
Source Wroclaw Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 2, 2019
Est. primary completion date May 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;

- the patients were treated first time using fixed orthodontic appliance;

- no systemic diseases;

- were not using anti-inflammatory drugs;

Exclusion Criteria:

- had used antibiotics in the previous 24 months;

- smokers;

- had history of radiotherapy,

- taking bisphosphonate medication

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Irradiation of implants with 635nm laser
Irradiation of implants with 635nm laser

Locations

Country Name City State
Poland Private Dental Healtcare Wschowa

Sponsors (1)

Lead Sponsor Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Pain level Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain. 24 hours
Other mini-implants loss 60 days
Primary stability of orthodontic mini-implants The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. [27] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects. 60 days
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